Specialist, QA Validation

About the Role

Join Jubilant HollisterStier LLC, Spokane’s largest manufacturing company and a leader in pharmaceutical and biopharmaceutical industries. We specialize in sterile injectable vials, lyophilized products, and allergenic extracts, supporting life-changing medicines globally. As part of the Jubilant Pharma family, we offer a dynamic environment for builders, innovators, and doers to make a meaningful impact.

Responsibilities

• Provide technical expertise via review and approval of documents, including Protocols, Acceptance Reports, SOPs, and Specifications.
• Support projects and clients as a quality representative.
• Collaborate with production, engineering, maintenance, IT, and technical services to ensure prerequisite documentation supports process, cleaning, facilities, aseptic, and filling/packaging activities.
• Track and provide technical direction for new and continued validation of processes and equipment to ensure compliance with internal policies, cGMPs, and regulatory requirements.
• Review product transfer protocols and reports, assess impact on product quality, and determine appropriate actions.
• Create and write required SOPs pertaining to documentation and QA Validation.
• Recognize compliance issues and provide QA SME support for change control and system improvement.

Qualifications

• Bachelor of Science or 5 years of experience in lieu of a degree.
• 2-5 years of related validation experience in an FDA-regulated industry (pharmaceutical, medical device, or food manufacturing).
• Minimum 2 years of pharmaceutical manufacturing experience preferred.
• SAP experience and project management skills desired.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• In-depth understanding of cGMPs, European regulatory requirements, USP chapters, and scientific principles associated with sterile product manufacturing and testing.
• Ability to provide QA SME support for change control, system improvement, risk assessments, and business development projects.

Location

Spokane, WA — On-Site, Full-Time

Schedule

Monday-Friday

Pay

Hiring Wage: $81,800.00 – $130,900.00, with opportunities for growth, promotion, and annual raises.

Benefits

• Medical, Dental, and Vision coverage starting on day one.
• Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA).
• Life and AD&D Insurance.
• Short-Term and Long-Term Disability Insurance.
• Employee Assistance Program.